Commissioning & Qualification Specialist

Flexible & Integrated Technical Services, LLC•Juncos, PR

About The Position

For Commissioning and Qualification services in the Capital Projects area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree in Life Science or Engineering and a minimum of five (5) years of experience in the regulated industry. Excellent written and verbal skills in both English and Spanish. Technical writing skills and problem-solving skills. Experience in: Facilities, utilities, drug substance, filling, inspection, and packaging areas. Equipment qualification. Validation concepts and life cycle process. Conceptual, detailed design, project planning, execution, and qualification. The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Validation Commissioning Qualification Technical Writing Protocol Drafting, Review, Execution Deviation Process Documentation Develop validation engineering policies and procedures that affect multiple organizational units. Supervise, coordinate, and review the work of a small staff of engineers and/or technicians on an ongoing basis and on a project basis. Employ advanced validation engineering techniques and/or modifications of advanced techniques within the area of validation engineering expertise. Apply knowledge of validation engineering principles and practices outside of the area of expertise to a wide variety of assignments in related fields. Develop technical solutions to complex problems that require regular ingenuity and creativity. Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. Work with project managers to complete engineering project validation within schedule, budget, and quality constraints. Develop departmental budgets or project budgets encompassing multiple disciplines for an area within a project or the entirety of a smaller project. Prompt and regular attendance at the workplace. BEING A FITS PIECE COMES WITH PERKS: One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out! WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the next piece?

Requirements

Bachelor’s Degree in Life Science or Engineering and a minimum of five (5) years of experience in the regulated industry.
Excellent written and verbal skills in both English and Spanish.
Technical writing skills and problem-solving skills.
Experience in:
Facilities, utilities, drug substance, filling, inspection, and packaging areas.
Equipment qualification.
Validation concepts and life cycle process.
Conceptual, detailed design, project planning, execution, and qualification.

Responsibilities

Validation
Commissioning
Qualification
Technical Writing
Protocol Drafting, Review, Execution
Deviation Process Documentation
Develop validation engineering policies and procedures that affect multiple organizational units.
Supervise, coordinate, and review the work of a small staff of engineers and/or technicians on an ongoing basis and on a project basis.
Employ advanced validation engineering techniques and/or modifications of advanced techniques within the area of validation engineering expertise.
Apply knowledge of validation engineering principles and practices outside of the area of expertise to a wide variety of assignments in related fields. Develop technical solutions to complex problems that require regular ingenuity and creativity.
Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.
Work with project managers to complete engineering project validation within schedule, budget, and quality constraints.
Develop departmental budgets or project budgets encompassing multiple disciplines for an area within a project or the entirety of a smaller project.
Prompt and regular attendance at the workplace.